Companies disclosing negative aspects in sustainability reports often employ legitimation strategies to present mishaps in a favorable light. In incentivized experiments, we find that nonprofessional investors divest from companies with a negative sustainability-related incident, and that symbolic legitimation (which only evasively explains a negative incident) is not a strong enough signal to counter this divestment behavior. Even substantial legitimation (which reports on measures and behavioral change) mitigates the divestment decisions only if the company reports on concrete remediation actions in morally (...) charged situations, such as social or environmental incidents. We elaborate these results in light of signaling and screening theory, and suggest the conceptual extension of “costly signals” to what we call “valuable signals.” We argue that valuable signals need be not only costly for the sender from an economic perspective but also perceived as appropriate by the receiver from a noneconomic perspective. (shrink)

To find more information about Rowman and Littlefield titles, please visit www.rowmanlittlefield.com.

In daily life, perceivers often need to predict and interpret the behavior of group agents, such as corporations and governments. Although research has investigated how perceivers reason about individual members of particular groups, less is known about how perceivers reason about group agents themselves. The present studies investigate how perceivers understand group agents by investigating the extent to which understanding the ‘mind’ of the group as a whole shares important properties and processes with understanding the minds of individuals. Experiment 1 (...) demonstrates that perceivers are sometimes willing to attribute a mental state to a group as a whole even when they are not willing to attribute that mental state to any of the individual members of the group, suggesting that perceivers can reason about the beliefs and desires of group agents over and above those of their individual members. Experiment 2 demonstrates that the degree of activation in brain regions associated with attributing mental states to individuals—i.e., brain regions associated with mentalizing or theory-of-mind, including the medial prefrontal cortex (MPFC), temporo-parietal junction (TPJ), and precuneus—does not distinguish individual from group targets, either when reading statements about those targets' mental states (directed) or when attributing mental states implicitly in order to predict their behavior (spontaneous). Together, these results help to illuminate the processes that support understanding group agents themselves. (shrink)

The sixteen essays in Gender Struggles address a wide range of issues in gender struggles, from the more familiar ones that, for the last thirty years, have been the mainstay of feminist scholarship, such as motherhood, beauty, and sexual violence, to new topics inspired by post-industrialization and multiculturalism, such as the welfare state, cyberspace, hate speech, and queer politics, and finally to topics that traditionally have not been seen as appropriate subjects for philosophizing, such as adoption, care work, and the (...) home. (shrink)

In this paper we will argue in favor of federal funding of elective abortion, more specifically in support of Medicaid funding. To do so, we will address the restrictions on public funding presently in place and demonstrate that the various justifications offered in their defense are in­adequate. We will then suggest that the ‘failure to enable’ represented by a ban on Federal funding is morally equivalent to an outright prohibition on abortion for the target population. Just as a moral equivalence (...) can be established between killing and letting die in symmetrical cases, like criteria for equivalence can be established that help to identify those failures to make possible that are morally indistinguishable from proscriptions. On this basis, it can be shown that restrictions on Federal funding in such contexts can be thought to carry the same moral liability as prohibitions. (shrink)

Eduard Seidler sets his discussion of the teaching of medical ethics in the Federal Republic of Germany against an historical background. Immediately after the Second World War the freshness of the memory of the 'Nuremberg Medical Trials' influenced the way in which moral dilemmas were treated in Germany. At the present time no systematic instruction in medical ethics is provided in either undergraduate or postgraduate or continuing medical education. As a result of this, an inquiry was set up in 1977/78. (...) Questionnaires were sent out with a view to collecting information on how subjects referring to medical ethics are treated during medical training. The inquiry showed that no special discipline can claim to be the only competent one for medical ethics, but that everyone has something to contribute. Dr Seidler concludes by stating that basic curricula related to the problems of medical ethics would have to be developed and should be carried on continuously within the training programme. (shrink)

REVISTA EDUCAÇÃO E FILOSOFIA é uma publicação semestral do Departamento de Pedagogia da Universidade Federal de Uberlândia. Este número é o primeiro fruto de um sonho antigo e de um inconformismo com a falta de um veículo como este, entre nós. Pretendemos incentivar e divulgar trabalhos de natureza interdisciplinar nas áreas de Educação e Filosofia. Mas, se a Revista vier a ter uma linha preferencial — e isto depende muito mais dos nossos colaboradores, que da direção — essa linha não (...) será exclusiva nem excludente, pois a Revista estará aberta às mais diversas correntes de pensamento, não se fechando, pois, com quaisquer grupos. Isto é consequência de nossa visão de Universidade como lugar onde se deve estimular a heterogeneidade de tendências e o debate. Entendemos que uma filosofia que propugne posições dogmáticas inviabiliza o debate sobre seus próprios pressupostos, deixando de ser filosofia para tornar-se mera ideologia. Ademais, a discussão de questões de princípio tem razão de ser e há momentos em que apenas ela pode contribuir para a superação de impasses de ordem teórica ou prática, sobretudo nas ciências sociais; somente uma abordagem crítica — o que equivale a dizer: sem preconceitos — pode contribuir para os debates de questões fundamentais tanto para a filosofia, quanto para a educação, ou ainda quanto para uma filosofia de educação. A REVISTA EDUCAÇÃO E FILOSOFIA deve representar um fórum de permanentes debates aberto a todo educador, todo pensador e, sobretudo, a todo pensador-educador. Propomo-nos a acolher e divulgar contribuições que sintetizem os resultados de investigações empíricas e teóricas e de projetos práticos, preferencialmente, mas não exclusivamente, desenvolvidos na região do Triângulo Mineiro. Dentro do princípio de que o caráter objetivo e preciso do conhecimento científico não é incompatível com os conformismos diante das injustiças de toda ordem, pretendemos, ainda, ser um estímulo aos balanços críticos. A REVISTA EDUCAÇÃO E FILOSOFIA é a soma do que temos e somos, mas será um veículo para atingirmos aquilo que queremos ser e ter. Deverá abrir caminho para a reflexão filosófica, a reflexão sobre educação, a reflexão sobre o ensino da filosofia e possibilitará o diálogo com os pensadores e educadores presentes e pretéritos visando à construção do futuro. Nós não teríamos sido justos se olvidássemos o empenho da professora Carmelita Vieira dos Santos, chefe do Departamento de Pedagogia para que, diante de tantos cortes de recursos, fossem mantidos aqueles destinados à revista. Nossos agradecimentos também à professora Marly Bernardes de Araújo, diretora do Centro de Ciências Humanas e Artes. Ao Conselho do Departamento de Pedagogia, nossa gratidão por ter acolhido a Revista. (shrink)

In response to rapidly rising health care costs in the United States, federal and state governments and private industry are instituting numerous and diverse cost-containment plans. As devices for coping with a scarcity of resources, such plans present serious challenges to physicians' traditional single-minded devotion to patient welfare. Those which contain costs by directly limiting medical options or by controlling physicians' daily clinical decisions can threaten the quality of medical care by allowing economic authorities to make essentially medical judgments. In (...) contrast, other plans coax compliance by arranging incentives, e.g., offering financial rewards for successful cost containment. While they allow for clinical freedom, these plans create conflicts between physicians' fiduciary obligations to their patients and the competing interests of the payers. Such conflicts arise as physicians try to work within governmental or corporate cost containment policies, and also as they attempt to streamline clinical efficiency. Throughout, issues of justice emerge as physicians seek to reconcile their own patients' claims upon limited common resources with others' equally legitimate claims. (shrink)

Although Business Ethics has become a topic of wide discussion in both academia and the corporate world, questions remain as how to present ethical issues in a manner that will effectively influence the decisions and behavior of business employees. In this paper we argue that the Federal Sentencing Guidelines (FSG) offer a unique opportunity for bridging the gap between the theory and practice of business ethics. We first explain what the FSG are and how they apply to organizations. We then (...) show how discussions of the FSG might be used in business ethics courses in a way that is both theoretically sound and practically applicable. Finally, we show how the requirements of the FSG can be used by companies to develop effective ethical compliance programs. As such, we maintain that the FSG provide a powerful heuristic tool for the teaching and training of business ethics. (shrink)

Researchers now commonly collect biospecimens for genomic analysis together with information from mobile devices and electronic health records. This rich combination of data creates new opportunities for understanding and addressing important health issues, but also intensifies challenges to privacy and confidentiality. Here, we elucidate the “web” of legal protections for precision medicine research by integrating findings from qualitative interviews with structured legal research and applying them to realistic research scenarios involving various privacy threats.

O presente artigo possui como tema a análise da separação dos poderes e a regra da democracia, além da possibilidade do Tribunal Constitucional ser composto por indivíduos nomeados pelo Presidente da República, não cumprindo a regra democrática, e fazer o controle de constitucionalidade das leis, criadas através de um processo democrático. Serão respondidos: a separação dos poderes obedece à regra democrática? Quando o Poder Legislativo deixa de cumprir sua função típica de legislar, abre a oportunidade para o Supremo Tribunal Federal, (...) como Tribunal Constitucional que é, criar, através do ativismo judicial, as normas lacunosas? Isso fere a regra democrática? (shrink)

A number of philosophers, linguists and psychologists have made the dual claim that metaphor is cognitively significant and that metaphorical utterances have a meaning not reducible to literal paraphrase. Such a position requires support from an account of metaphorical meaning that can render metaphors cognitively meaningful without the reduction to literal statement. It therefore requires a theory of meaning that can integrate metaphor within its sematics, yet specify why it is not reducible to literal paraphrase. I introduce the idea of (...) a "second-order meaning", of which metaphor is but one instance, that is a function on literal-conventional, i.e., first-order meaning, and outline a linguistic framework designed to provide a representation of linguistic meaning for both. This framework is designed to represent linguistic units ranging from a single word to an entire text since I argue that the by-now familiar position that the sentence is the appropriate unit for metaphor has mislead us into asking the wrong questions about metaphorical meaning. With this apparatus, we can specify the conditions under which an utterance may transcend the constraints on first-order meaning (transgressions not always apparent on the sentential level), without thereby being "meaningless". Conversely, we can specify the conditions that may render apparently odd utterances first-order meaningful rather than metaphorical. In this way we see how metaphorical language differs both from deviant language and from specialized language such as technical language, fanciful and fantastical language (in fairy tales, science fiction, etc.). (shrink)

The federal government's introduction in 1983 of DRG‐based reimbursement for Medicare patients shook the entire health care industry into the vigorous and dramatic cost containment efforts which today are reshaping health care in America.

For eight years Medical Psychology has been an integral part of medical pre-examination as well as of research and teaching in the Federal Republic of Germany, and a great deal of psychological knowledge is taught to the medical student under this heading. Besides mere theory the medical student is supposed to acquire behavior based on psychological findings which will be important to him in medical practice. Nevertheless, students often complain that teaching is too far from reality, due to the fact (...) that Medical Psychology is part of the first, more theoretical, period of medical eduction, even though one of the main objects of this new field is the analysis of the interaction between patient and physician. (shrink)

With disparate rates of morbidity and mortality among minoritized communities, COVID-19 illuminated the need for equity-informed practices in public health. Pacia et al posit FQHCs as entities that addressed inequity when others failed. This commentary further situates how FQHCs address the public health crisis of institutional racism and related health inequities every day and presents a FQHC-led Ethics and Equity Framework and Workflow Checklist to guide ethical and equitable engagement with FQHCs.

When surgeons transplant animal organs into humans, people who did not receive the organs incur risks. These third parties may stand near or far in time or space. No one knows the likelihood, breadth, or nature of the risks in question. The common wisdom among infectious-disease specialists is that in the best of xenotransplant conditions, such third-party risk may be minimized but not eliminated.

Human clinical research trials, by which corporations, universities, and research scientists bring new drugs, devices, and procedures into the practice and marketplace of medicine, have become a huge business. The National Institutes of Health doubled its spending over the past five years, while in the private sector the top twenty pharmaceutical companies have more than doubled their investment in research and development over a roughly comparable period. To date, some twenty million Americans have participated in clinical research trials that now (...) are as common in the private practice setting as in academia.For many years human clinical trials received relatively little public attention. In the wake of several well-publicized research abuses, Congress created in 1974 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to formulate recommendations to protect human research subjects. The Commission’s 1979 Belmont Report helped to guide the Institutional Review Boards that review the ethics of federally funded research. (shrink)

In this brief paper, offered as a policy viewpoint, I introduce what I believe to be a novel concept for supporting individual citizen interaction with the U.S. Federal government, termed the individual social account. I explore whether and how the concept might be implemented so as to strengthen the U.S. social safety net and further citizen trust and responsibility in e-government interactions. I illustrate and develop the concept as a platform for reform and suggest and discuss design criteria, surfacing various (...) issues. I conclude with additional thoughts with which to stimulate further research and discussion of the concept and its practicalities. (shrink)

Reprints the only English translation of Rousseau's development of the Projet pour rendre la paix perpétuelle en Europe by l'Abbé de Saint-Pierre. The introduction, written for this edition, provides an illuminating comparison of the two thinkers. Fragments of the essay on "The State of War" are also included.--E. T.

Conducting or overseeing research in correctional settings requires knowledge of specific federal rules and regulations designed to protect the rights of individuals in incarceration. To investigate the extent to which relevant groups possess this knowledge, using a 10-item questionnaire, we surveyed 885 IRB prisoner representatives, IRB members and chairs with and without experience reviewing HIV/AIDS correctional protocols, and researchers with and without correctional HIV/AIDS research experience. Across all groups, respondents answered 4.5 of the items correctly. Individuals who have overseen or (...) conducted correctional research had the highest scores; however, even these groups responded correctly only to slightly more than half of the items. These findings emphasize the need for ongoing training in federal guidelines governing correctional research, particularly for those individuals who are embarking on this type of research. (shrink)

Complaints are common about the arbitrary and conservative bias of special-majority rules. Such complaints, however, apply to asymmetrical versions of those rules alone. Symmetrical special-majority rules remedy that defect, albeit at the cost of often rendering no determinate verdict. Here what is formally at stake, both procedurally and epistemically, is explored in the choice between those two forms of special-majority rule and simple-majority rule; and practical ways are suggested of resolving matters left open by symmetrical special-majority rules – such as (...) ‘judicial extrapolation’ or ‘subsidiarity’ in a federal system. (shrink)

A collection of essays, speeches, and conversations from a conference sponsored by Southwestern University Law Review and held in Los Angeles in 1977 in commemoration of the 190th anniversary of the Constitution, this book has some 36 contributors. The majority of these are law professors, including Laurence Tribe of Harvard, Bernard Schwartz of NYU, Ruth Bader Ginsburg of Columbia, Lino A. Graglia of the University of Texas, and Martin Shapiro of the University of California at Berkeley. Several contributions are by (...) Federal judges, including ones by Charles E. Wyzanski, Jr., and Constance Baker Motley. There is also a sprinkling of historians, political scientists, journalists, and lawyers. The contributors include a number of little known, as well as many well-known commentators on the Constitution. (shrink)

About 6% of women in the world live in countries that ban all abortions, and 34% in countries that only allow abortion to preserve maternal life or health. In the USA, over the last decades—even before Dobbs v. Jackson Women’s Health Organization overturned the federal right to abortion—various states have sought to restrict abortion access. Often times, this legislation has been advanced based on legislators’ personal moral values. At the bedside, in contrast, provision of abortion care should adhere to the (...) normative principles of medical ethics and reproductive justice, centreing patients and their individual reproductive intentions and desires. Abortion regulations, through their influence on patients and providers, may facilitate or impede such ethical care at the bedside. In this paper, we present a framework to model how abortion legislation should fit into the patient–provider relationship and to clarify the dynamics by which legislation may affect healthcare encounters. Our proposed framework serves as a tool to analyse the ethical impact of abortion regulations. We propose a model for assessing abortion policies based not on legislators’ or advocates’ individual moral claims, but on the shared, normative framework of clinical medical ethics. Through contrasting case studies, we demonstrate how a robust normative ethical framework can recentre patients and their reproductive needs. Our model is one way to account for—and safeguard—patients’ diverse viewpoints and needs in the development of abortion policy, and it can serve to ground narratives for advocacy by healthcare workers and their professional organisations. (shrink)

Book reviewed:Eva Feder Kittay, Love's Labor: Essays on Women, Equality, and Dependency.

This paper focuses on the 1986 Amendments to the False Claims Act of 1863, which offers whistle-blowers financial rewards for disclosing fraud committed against the U.S. government. This law provides an opportunity to examine underlying assumptions about the morality of whistle-blowing and to consider the merits of increased reliance on whistle-blowing to protect the public interest. The law seems open to a number of moral objections, most notably that it exerts a morally corrupting influence on whistle-blowers. We answer these objections (...) and argue that the law is not objectionable on these grounds. Since there are no compelling moral objections to the law, it is appropriate and acceptable to judge the law in terms of its economic costs and benefits. We assess the most salient of these and conclude that the benefits outweigh the costs. We suggest that a mechanism similar to the Act should be considered for protecting stockholders' interests in the private sector. We conclude by making several proposals for improving the existing legislation. (shrink)

This article was delivered as a public lecture at the Universidade Federal do Rio de Janeiro, March 24, 2015. It discusses normative information and library ethics and then formal and critical information and library ethics, the latter being the preconditions to the existence of information access and user’s choices. Information professionals have strong responsibilities in creating the possibilities for information, and therefore, for truth and rights to truth, by their choices in constructing and making available or not information. Professional formal (...) and critical ethics are, thus, preconditions to information access and choices by users. ÉTICA INFORMACIONAL: AS PERSPECTIVAS NORMATIVA E CRÍTICA ResumoEste artigo foi apresentado como conferência pública na Universidade Federal do Rio de Janeiro, em 24 de março de 2015. Discute regras referentes à informação e a ética biblioteconômica e, daí, critérios formais e críticos para a informação e a ética biblioteconômica, a última como precondição para existência do acesso à informação e escolha dos usuários. Os profissionais da informação têm grande responsabilidades na criação de possibilidades para informação e, daí, à verdade e ao direito à verdade, a partir de suas escolhas na construção e no fazer acessível ou não a informação. Critérios formais e ética crítica são, então, precondições para o acesso e escolha de informações pelos usuários. (shrink)

In 2005, The International Federation of Organic Agricultural Movements (IFOAM) developed four new ethical principles of organic agriculture to guide its future development: the principles of health, ecology, care, and fairness. The key distinctive concept of animal welfare in organic agriculture combines naturalness and human care, and can be linked meaningfully with these principles. In practice, a number of challenges are connected with making organic livestock systems work. These challenges are particularly dominant in immature agro-ecological systems, for example those that (...) are characterized by industrialization and monoculture. Some of the current challenges are partly created by shortages of land and manure, which encourage zero-grazing and other confined systems. Other challenges are created in part by the conditions for farming and the way in which global food distribution systems are organized, e.g., how live animals are transported, how feed is traded and transported all over the globe, and the development of infrastructure and large herds. We find that the overall organic principles should be included when formulating guidelines for practical organic animal farming. This article explores how the special organic conceptions of animal welfare are related to the overall principles of organic agriculture. The aim is to identify potential routes for future development of organic livestock systems in different contexts and with reference to the specific understanding of animal welfare in organic agriculture. We include two contrasting cases represented by organic livestock systems in northwestern Europe and farming systems in tropical low-income countries; we use these cases to explore the widely different challenges of organic livestock systems in different parts of the world. (shrink)

A book of readings in Western intellectual history focusing on the role of reason in human action. Contents:^ Plato: Myth of the Cave; Plato: ^IThe Four Virtues; Aristotle: Knowledge of Causes; Aristotle: The Types of Governments; Epicurus: Epicureanism; Epictetus: Stoicism; St. Augustine: The Platonist; St. Augustine: The Nature of Sources of Evil; St. Thomas Aquinas: The Four Laws; St. Thomas Aquinas: The Nature of the Soul; Pico: The Oration on the Dignity of Man; John Calvin: Reason, Sin and Illumination; St. (...) Teresa of Avila: Interior Castle; Rene Descartes: Pens,s ; Thomas Hobbes: The State of Nature; John Locke: The State of Nature; Alexander Pope: Essay on Man; David Hume: Impressions and Ideas; Voltaire: Candide; Immanuel Kant: Space and Time; Immanuel Kant: The Good Will; Edmund Burke: Revolution in France; James Madison: The Federal Government; Soren Kierkegaard: Subjective Truth; Fyodor Dostoevsky: The Grand Inquisitor; Karl Marx and Friedrich Engels: Communist Manifesto; Friedrich Nietzsche: The Will to Power; William James: Pragmatism; William James: Philosophical Temperaments; Sigmund Freud: The Ego and the Id; Ludwig Wittgenstein: Later Theory; Jean-Paul Sartre: Existentialism; Carol Gilligan: Women's Place in Man's World; Appendix: Programmed Text on Epistemology. (shrink)

The United States Court of Appeals for the District of Columbia Circuit held that the district court did not have jurisdiction over the American Chiropractor's Association's federal question claims brought under the Medicare Act, despite affirming the ACA's prudential standing to pursue its claims. The Appeals Court reversed the lower court's decision allowing a doctor of medicine or osteopathy to perform manual manipulations of the spine on Medicare beneficiaries to correct a subluxation.The Medicare program “subsidizes medical insurance for elderly and (...) disabled persons.” An enrollee selects a physician or obtains medical services through a managed-care provider, such as a health maintenance organization. (shrink)

Ethics in scientific research has never been more important. Recent controversies over the integrity of data in federally funded science, the manipulation and distortion of privately sponsored research, cloning, stem cell research, and the patenting of DNA and cell lines, illustrate the need for a more thorough education in ethics for researchers at all levels. Now in its second edition, Responsible Conduct of Research provides an introduction to many of the social, ethical, and legal issues facing scientists today. The fully (...) updated volume includes three brand new chapters and additional cases for discussion, as well as analysis of the latest issues and problems in research ethics. Featuring chapters that treat such topics as ethical decision-making, research misconduct, and intellectual property, this new edition will be an indispensable resource for students and teachers, academics and industry professionals alike. (shrink)

Since the turn of the century, the number of small-scale farmers in the U.S. and farmlands they owned have declined very sharply (structural change). Although the decrease in number is generally true for both white and Black farm operators, it has been more significant for Blackfarm operators than whites. The declining trend in the number of Blackfarm operators in the country is derived from individual state experiences that resulted from a combination of various political and economic factors. Using the census (...) of agriculture data from 1900 to 1987, this paper gives a brief historical overview of Black farm operators in Maryland. The census data for the study period shows that at their peak number in 1910, there were 6,382 Blackfarmers in the state of Maryland. However, by 1987, only 371 of that number remained, representing a loss of 94 percent since 1910. According to the 1987 census data almost all Black operated farms in Maryland were not only small-scale but also in the lower sales class, less than $20,000 a year. Their household net family income is below that of non-metropolitan median household income. This concentration of Blacks in the lower economic class of farm operators in the state, for the most part, is closely related to their resource endowments, patterns of tenure, type of farm enterprises, and government farm programs and policies. On the average, Blackfarmers in Maryland have less land, capital and management skills than their white counterparts. Government policies and programs had, and continue to have, a devastating effect on Maryland Black farmers because they were tied to productive resources rather than farm income needs. Under conditions of low income, years of neglect by federal and state programs and policies, and limited resources Blackfarmers were unable to adopt capital intensive production practices and expand their farm operations. This resulted in most of them leaving agriculture, in the past and today, at a faster rate than whites. To avert or at least lessen the unfortunate situation of Black farm operators, projections and possible solutions are offered. This includes how the 1890 Land-Grant institutions because of their tradition, expertise and experience of research, teaching and outreach can take the leadership role in shaping the future direction of these farmers and their operations. (shrink)

Biomedical and behavioral research may affect strongly held social values and thereby create significant controversy over whether such research should be permitted in the first place. Institutional review boards responsible for protecting the rights and welfare of participants in research are sometimes faced with review of protocols that have significant implications for social policy and the potential for negative social consequences. Although IRB members often raise concerns about potential long-term social implications in protocol review, federal regulations strongly discourage IRBs from (...) considering them in their decisions. Yet IRBs often do consider the social implications of research protocols and sometimes create significant delays in initiating or even prevent such research. The social implications of research are important topics for public scrutiny and professional discussion. This article examines the reasons that the federal regulations preclude IRBs from assessing the social risks of research, and examines alternative approaches that have been used with varying success by national advisory groups to provide such guidance. The article concludes with recommendations for characteristics of a national advisory group that could successfully fulfill this need, including sustainability, independence, diverse and relevant expertise, and public transparency. (shrink)

Education in the responsible conduct of research (RCR) in the United States has evolved over the past decade from targeting trainees to including educational efforts aimed at faculty and staff. In addition RCR education has become more focused as federal agencies have moved to recommend specific content and to mandate education in certain areas. RCR education has therefore become a research-compliance issue necessitating the development of policies and the commitment of resources to develop or expand systems for educating faculty and (...) staff and for assuring compliance. These changes implied the need to develop a program evaluation model that could be applied to institutional RCR education programs, which were expected to differ from traditional academic credit-bearing courses targeting trainees. Information gleaned from the examination of corporate compliance models was analyzed in order to create a program evaluation module that could be used to document and assess educational programs focused on teaching RCR. A programmed series of questions for each of the nine RCR content areas identified by the United States Office of Research Integrity was created based on a performance-monitoring evaluation model. The questions focus on educational goals, resources provided to support the educational efforts, educational content, content delivery, educational outcomes, compliance requirements and feedback. Answers collected in response to the questions could be used to both document and continually improve the quality of RCR educational programs through on-going formative assessment and feedback. (shrink)

Deep brain stimulation — a novel surgical procedure — is emerging as a treatment of last resort for people diagnosed with neuropsychiatric disorders such as severe obsessive-compulsive disorder. The US Food and Drug Administration granted a so-called humanitarian device exemption to allow patients to access this intervention, thereby removing the requirement for a clinical trial of the appropriate size and statistical power. Bypassing the rigors of such trials puts patients at risk, limits opportunities for scientific discovery, and gives device manufacturers (...) unique marketing opportunities. We argue that Congress and federal regulators should revisit the humanitarian device exemption to ensure that it is not used to sidestep careful research that can offer valuable data with appropriate patient safeguards. (shrink)